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SureFlo EVD Catheter

by Arkis Biosciences Inc.

510(k) K170599

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170599 Date31 Aug 2017ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2173-2026 FDA Class II initiated 10 Apr 2026

    Out-of-specification endotoxin result that did not meet the acceptance criteria.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JXG
FDA applicant
Arkis Biosciences, Inc.
Device Class
Class II
Regulation
21 CFR Part 882.5550
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent